MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B; STIMULATOR, SPINAL PAK, NON-INVASIVE (63B ELECTRODES)

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Surgical procedures: posterior lumbar fusion using bilateral peek expandable grafts with interbody arthrodesis l4-l5, l5-s1.Medical product: pedicle screws.Medical product: pedicle rod.Medical product: biomet polaris t.Therapy date: unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The patient reported that she started having issues with the 63b electrodes after wearing them for 4 hrs.The patient said that she could not use the unit at all.The patient had confirmed, in (b)(6) 2021, that the doctor was not happy that the 63b electrodes (and 72r electrodes) caused irritation and blisters.The doctor decided that it was best to stop treatment.

Event Description

The patient reported that she started having issues with the 63b electrodes after wearing them for 4 hrs.The patient said that she could not use the unit at all.The patient had confirmed, in july 2021, that the doctor was not happy that the 63b electrodes (and 72r electrodes) caused irritation and blisters.The doctor decided that it was best to stop treatment.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.The following sections have been updated: b4 date of this report updated d3: manufacturer g1: contact office g3 date received by manufacturer g6: type of report g6: type of report updated h2: follow up type updated h3: device evaluated by manufacturer updated to yes h4 device manufacturer date added h6: component codes added 451-electrodes h6: impact code added 4648-insufficient information h6: clinical code added 4545 - skin inflammation/ irritation h6: device code updated to 2682 - patient-device incompatibility h6: investigation code added to 3331 - analysis of production records h6: investigation code added to 4119 ¿ insufficient information available h6: investigation findings code added to 3221: no findings available h6: investigation conclusion added to 4315- cause not established h10: additional narratives/data the following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (63B ELECTRODES)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12327064
• MDR Text Key: 267277772
• Report Number: 0002242816-2021-00140
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-22
• Device Lot Number: 020001
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female